Please ensure Javascript is enabled for purposes of website accessibility
top of page

Drug Regulation in the Era of Individualized Therapies

Janet Woodcock, M.D., and Peter Marks, M.D., Ph.D. (NEJM)

October 24, 2019


Kim et al., in a report now published in the Journal,1 describe the discovery, development, and administration of an antisense oligonucleotide (ASO) therapy specifically designed for a single patient with CLN7 neuronal ceroid lipofuscinosis (a form of Batten’s disease), a fatal genetic neurodegenerative disorder.2 In this patient, a known pathogenic point mutation was found to be present in one copy of the gene MFSD8 (also known as CLN7), and a previously undescribed insertion of a retrotransposon was present in the other copy. Retrotransposons are stretches of DNA that are sometimes described as mobile elements; thousands are present in the human genome, and some are capable of moving to a new location — such as the middle of a gene — through a “copy and paste” mechanism.



N Engl J Med 2019; 381:1678-1680


DOI: 10.1056/NEJMe1911295

26 views

Comments


bottom of page